Laboratory Quality Assurance​/Compliance Coordinator

PERFORM ADDITIONAL DUTIES AS ASSIGNED.

This position will report to the Laboratory Clinical and Administrative Services Associate Director. As the Quality/Compliance Program Coordinator this position will support the program and provide technical expertise in quality management, compliance and risk management. Utilizing technical expertise, analytical skills and critical thinking, provide oversight of regulatory changes, evaluation and monitoring of laboratory practices and auditing of Quality and Compliance improvement activities to ensure timely and effective resolution.

• Conduct internal quality & compliance audits across all areas of the laboratory to include Clinical and Anatomic Pathology to ensure ongoing compliance to regulatory requirements, accreditation standards, and document results of the audits.
• Evaluate, coordinate, and monitor current laboratory quality & compliance activities across all areas of the laboratory.
• Support surveillance of external regulatory bodies for changes to Quality and Compliance standards and rules.
• Evaluate, develop, and improve the timeliness and effectiveness of resolving quality and compliance issues.
• Continues to evaluate and improve the lab quality and compliance process which includes identification, surveillance, logging, prioritizing, tracking/reporting, and program assessment.

• Minimum five (5) years of relevant experience in a high-complexity clinical laboratory or similar environment.

• Bachelor of arts or science in biomedical laboratory science, clinical science, or a related field.

• Medical Lab Scientist Certificate required at hire.

• Strong independent analysis and problem solving skills.
• Ability to proactively communicate with consistency, clarity, and honesty.
• Strong attention to detail with effective written and verbal communication skills.
• Strong technical skills and job and industry knowledge.

• Two (2) years of experience as laboratory quality or compliance coordinator.
• Skills in report development regarding quality and compliance.
• Experience in analyzing and resolving complex laboratory clinical and operational issues in a dynamic cross-functional environment.
• Possess advanced working knowledge of local, state, and federal laboratory regulations and accreditation.
• Legal background.